510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944600Substantially Equivalent

Graham-Field Saline Electrolyte Gel

Chester Labs, Inc., Erlanger KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944600 is the FDA 510(k) clearance record for GRAHAM-FIELD SALINE ELECTROLYTE GEL, a class II device, cleared for Chester Labs, Inc. on under FDA product code GYB (Media, Electroconductive). FDA records list 11 510(k) clearances for Chester Labs, Inc., from to . As of , FDA records show no recalls naming K944600.

Clearance record

Decision date
Received
(427 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Chester Labs, Inc. 3208 Dixie Hwy., Erlanger KY
510(k) summary
Statement
Third party review
No

Clearances, product code GYB

Trailing 12 months

FDA records hold no clearances under product code GYB in the trailing twelve months.

FDA records show no clearances under product code GYB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260